ECM Plug Shaft for Vessel Closure Hemostasis
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Solution Overview
Problem
Current devices for closing blood vessel openings after vascular procedures often fail to provide effective acute hemostasis and a conducive environment for rapid healing.
Innovation Solution
A device comprising a plug shaft and caps made from ECM material, which are porous and blood-absorbing, expandable, and compressible, designed to be inserted into a blood vessel opening, providing a snug seal and matrix for healing, with optional features like porcine small intestine submucosa and bio-degradable materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional pressure-based hemostasis is used, then acute hemostasis is achieved, but a conducive environment for rapid healing is not provided
Solution Approach 1:
The plug shaft is made from a porous ECM material that allows blood to penetrate through it. This porosity enables the material to absorb blood while maintaining structural integrity, creating an environment that supports both immediate hemostasis and subsequent tissue ingrowth and healing
Solution Approach 2:
The device combines multiple materials with different properties: the porous ECM material for blood absorption and tissue integration, and the compressible cap material for mechanical sealing. This composite approach provides both acute hemostasis through the cap compression and long-term healing through the ECM material's biological properties
2Ease of operation
If a large delivery device is used for percutaneous access, then the procedure can be performed, but effective acute hemostasis is not achieved
Solution Approach 1:
The caps are designed to be compressible during insertion through the delivery device, allowing them to pass through the access site in a compact state. Once deployed, the caps expand to their original larger diameter to provide effective sealing and hemostasis, dynamically adapting to the requirements of both delivery and function
3Duration of action of moving object
If the plug shaft is made porous and blood-absorbing, then a matrix for healing is provided, but the device complexity increases
Solution Approach 1:
The invention merges multiple functions into a single integrated plug shaft structure. The porous ECM material simultaneously provides blood absorption, structural support, and a biological matrix for tissue ingrowth and healing, eliminating the need for separate components for each function and thereby reducing overall device complexity
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device achieves rapid and effective acute hemostasis and long-term healing by expanding within the vessel to form a tight seal and anchor securely, facilitating blood coagulation and tissue integration.
Implementation Method 1
The plug shaft is preferably porous and blood absorbing
Implementation Method 2
The material's surface properties promote blood adhesion and coagulation
Implementation Method 3
The plug shaft... expands in the opening
Data Source
AI summary
A device for closure of an opening in a medical patient's blood vessel wall is disclosed. It discloses a plug shaft which is: porous; blood absorbing; insertable in an opening in a blood vessel wall; and, at least partially comprises an ECM material. A first cap which is integral with the plug shaft at a proximal end thereof is disclosed. A second cap is integral with the plug shaft. An insertion tube, a pusher, surgical methods of use, and kits, are also disclosed.